Alvesco 80 Inhaler
Last Updated on eMC 07-Jun-2017 View document | AstraZeneca UK Limited Contact details
Versions
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 07-Jun-2017 and displayed until Current
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 30-May-2017
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2 – Change to posologySection 5.1 – Addition of information relating to a trial
Section 7 – Deletion of Takeda as MAH and addition of AstraZeneca as MAH
Section 8 – Change to licence number
Section 10 – Amendment to date of revision of text
Updated on 15-Jul-2014 and displayed until 07-Jun-2017
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 19-May-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
4.2 Posology and method of administration: Added: Elderly and patients with renal or hepatic impairment Method of administration Precautions to be taken before handling or administering the medicinal product Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. 5.2 Pharmacokinetic properties: Renal or hepatic insufficiency, elderly changed to Elderly No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 10. DATE OF REVISION OF THE TEXT
Deleted:Specific patient groups
Added:Paediatric population
Added:
4.8 Undesirable effects - how to report:
Renal or hepatic impairment seperate heading
6.6 Special precautions for disposal and other handling:
Added:
Changed to: 19th May 2014
Updated on 18-Dec-2012 and displayed until 15-Jul-2014
Reasons for adding or updating:
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 30-Nov-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 7: Change to Marketing Authorisation Holder to Takeda GmbHSection 10: Change to Date of Revision of Text to 30/11/12
Updated on 09-Jun-2011 and displayed until 18-Dec-2012
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC: 18-May-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Addition of wording to sections 4.4 and 4.8 following an MHRA request regarding "Risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids".Updated on 25-Feb-2010 and displayed until 09-Jun-2011
Reasons for adding or updating:
- Change to section 9 - Date of first Authorisation/renewal of the Authorisation
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 11-Nov-2009
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
6 April 2004/28th September 2009
10. DATE OF REVISION OF THE TEXT
19 February 2009 11th November 2009
Updated on 23-Nov-2009 and displayed until 25-Feb-2010
Reasons for adding or updating:
- Removal of Black Triangle
Date of revision of text on the SPC: 11-Nov-2009
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
In section 1, the Black Triangle Symbol has been removed.Updated on 21-Apr-2009 and displayed until 23-Nov-2009
Reasons for adding or updating:
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 19-Feb-2009
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 4.8, Undesirable Effects, has been updated to change the frequency of some of the adverse events.Updated on 02-Feb-2009 and displayed until 21-Apr-2009
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC: 24-Nov-2008
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Changes to Sections 4.2 and 5.1 to clarify the high dose regimen following a Commission Decision after repeat use MRP.Updated on 25-Feb-2008 and displayed until 02-Feb-2009
Reasons for adding or updating:
- Change to section 7 - Marketing Authorisation Holder
- Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
- Change to section 10 date of revision of the text
- Company name change or merger
Date of revision of text on the SPC: 01-Jan-2008
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Updated on 31-May-2007 and displayed until 25-Feb-2008
Reasons for adding or updating:
- Correction of spelling/typing errors
Updated on 29-May-2007 and displayed until 31-May-2007
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic Properties
- Change to section 5.3 - Preclinical Safety Data
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 01-Jan-2007
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Fifth paragraph: Fourth sentence - ' In this situation, ......etc.. (ending with) ....Severe asthma exacerbations should be managed in the usual way.
4.4 Last paragraph: 'Concomitant treatment ......etc (ending with) ....(see section 4.5)'
4.5 Second paragraph: 'In a drug-drug interaction study.............etc (ending with) ...risk of systemic side effects of corticosteroids.'
5.1 Last paragraph: 'In a 12-week study of 680 severe asthmatics .........................(ending with) day of ciclesonide respectively'.
5.3 Third paragraph: ' A treatment-related effect.......etc (ending with) to humans is unknown'.
10 Date of revision of the text - January 2007
AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
+44 (0)1582 838 000
+44 (0)1582 838 003
+44 (0)1582 836 000
0800 783 0033
+44 (0)1582 837 837
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